Label:
ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE CAPSULES, 25 MG / 200 MG- aspirin and extended - release dipyridamole capsul...
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  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 14, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULES safely and effectively. See full prescribing information for ASPIRIN AND ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Aspirin and Extended-Release Dipyridamole Capsule is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to ...
  • 2 DOSAGE AND ADMINISTRATION
    Aspirin and Extended-Release Dipyridamole Capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets. The recommended dose of Aspirin and ...
  • 3 DOSAGE FORMS AND STRENGTHS
    25 mg/200 mg capsules are imprinted in black with ‘PAR’ on the cap and ‘730’ on the body, containing yellow colored extended-release pellets incorporating dipyridamole and a white to off white ...
  • 4 CONTRAINDICATIONS
    4.1 Hypersensitivity - Aspirin and extended-release dipyridamole is contraindicated in patients with known hypersensitivity to any of the product components. 4.2 Allergy - Aspirin is ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Risk of Bleeding - Aspirin and extended-release dipyridamole increases the risk of bleeding. Risk factors for bleeding include the use of other drugs that increase the risk of bleeding (e.g. ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity [see Contraindications (4.1)] • Allergy [see Contraindications (4.2)] • Risk of Bleeding ...
  • 7 DRUG INTERACTIONS
    7.1 Drug Interaction Study Information Obtained From Literature - Adenosinergic agents (e.g., adenosine, regadenoson) Dipyridamole has been reported to increase the plasma levels and ...
  • 8  USE IN SPECIFIC POPULATIONS
    8.1  Pregnancy - Risk Summary - Available data from published studies and postmarketing experience with aspirin and extended-release dipyridamole use during pregnancy have not identified a clear ...
  • 10 OVERDOSAGE
    Because of the dose ratio of dipyridamole to aspirin, overdosage of aspirin and extended-release dipyridamole is likely to be dominated by signs and symptoms of dipyridamole overdose. In case of ...
  • 11 DESCRIPTION
    Aspirin and Extended-Release Dipyridamole Capsules are a combination of aspirin and dipyridamole, antiplatelet agents, intended for oral administration. Each hard gelatin capsule contains 200 mg ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The antithrombotic action of aspirin and extended-release dipyridamole is the result of the additive antiplatelet effects of dipyridamole and ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In studies in which dipyridamole was administered in the feed to mice (up to 111 weeks in males and females) and rats (up to 128 weeks ...
  • 14 CLINICAL STUDIES
    ESPS2 (European Stroke Prevention Study-2) was a double-blind, placebo-controlled, 24-month study in which 6602 patients over the age of 18 years had an ischemic stroke (76%) or transient ischemic ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Aspirin and Extended-Release Dipyridamole Capsules are available as a hard gelatin capsule, with a red colored cap and an ivory-colored body, containing yellow colored extended-release pellets ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). • Risk of Bleeding -   Inform patients that as with other antiplatelet agents, there is a general risk of ...
  • Patient Information
    Aspirin and extended-release dipyridamole capsules - (as-per-in / ik-sten-did – ree-lees - dahy-pir-i-duh-mohl) Read this Patient Information before you start taking aspirin and extended-release ...
  • Package/Label Display Panel
    MAJOR® NDC 0904-7056-99 - Unit Dose - Aspirin and - Extended-Release - Dipyridamole - Capsules - 25 mg/200 mg - 20 CAPSULES (5 x 4) Rx only
  • INGREDIENTS AND APPEARANCE
    Product Information